A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.

NCT ID: NCT00381212

Last Updated: 2009-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-11-30

Brief Summary

To Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression.

Detailed Description

Although an HIV infection can induce weak immune responses, current HIV immunotherapy using consensus antigens has not shown consistent clinical activity. The absence of clinical activity is associated with an inability to raise cytotoxic T lymphocytes (CTL) against HIV antigens and a failure to induce T cell memory. While strong immune responses may be generated to a consensus antigen, those responses do not offer antiviral protection against a patient's individual viral burden. The infecting virus' antigen variability likely prevents the establishment of effective CD4+ T cell memory and a strong CD8+ T cell effector arm.

We are investigating the induction of CTL responses in HIV-infected subjects by a novel HIV immunotherapeutic agent (AGS-004) in an effort to overcome the lack of polyvalent specificity of the immune response for autologous HIV antigens which has been one of the primary reasons for the failure of HIV immunotherapy to date.

This pilot study will investigate the safety and immunologic activity of AGS-004 an autologous HIV immunotherapeutic agent.

Conditions

HIV Seropositivity; Acquired Immunodeficiency Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

AGS-004 immunotherapeutic injections.

Group Type: EXPERIMENTAL

AGS-004

Intervention Type: BIOLOGICAL

Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.

Interventions

AGS-004

Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.

Intervention Type: BIOLOGICAL

Other Intervention Names

AGS-004 immunotherapeutic

Eligibility Criteria

Inclusion Criteria

• Men or women age 18 years and over,
• Documented HIV-1 infection,
• Durable viral suppression (≤ 200 copies HIV-1 RNA / mL) on first ART regimen for at least 12 weeks prior to entry,
• Availability of ≥ 2.5mL of continually-frozen plasma before starting ART (≥30,000 copies/mL),
• CD4+ T cell count ≥200 cells/mm3 at time of pre-ART sample,
• CD4+ T cell count of ≥350 cells/mm3 obtained within 4 weeks of study entry,

Exclusion Criteria

• No co-infection with HBV or HCV,
• No history of lymph node irradiation or dissection,
• No prior use of any HIV vaccine,
• No use of hydroxyurea,
• No use of systemic corticosteroids or other non-permitted medications,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Montréal

OTHER

Sponsor Role: collaborator

Argos Therapeutics

INDUSTRY

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

McGill University Health Centre

Principal Investigators

Jean-Pierre Routy, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

Immunodeficiency Service/Montreal Chest Institute

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CAN-HIV-001

Identifier Type: -

Identifier Source: secondary_id

CTN229

Identifier Type: -

Identifier Source: secondary_id

BMB#06-003

Identifier Type: -

Identifier Source: org_study_id